Deepening Uncertainty on How the EU May Regulate Supposable Endocrine Disruptors by Gio Batta Gori

“The German Federal Institute for Risk Assessment (BfR) convened an international group of scientists on April 11e12, 2016, aiming at reconciling contrasting arguments on whether and how the EU Commission could regulate substances called endocrine disruptors (EDs) as a distinct class of hazards,” wrote Gio Batta Gori, D.Sc., M.P.H., in an online editorial in Regulatory Toxicology and Pharmacology 24 June 2016. The meeting produced an ambiguous consensus statement, ‘Scientific principles for the identification of endocrine disrupting chemicals,’ arguing for hazard-based regulation of EDs, dismissing the relevance of potency, thresholds and dose-response dynamics, and without offering operational guidance on how EDs should be regulated …

“Halas, hazard-based EDs regulation − needed or not − might end up driven by incited public anxieties and uncritical statutes, despite the epidemiologic safety of food, medicines and cosmetics. As this unfolds also in Canada and Japan, we shall contemplate the surging novelty of regulating supposable hazards in search of supposable diseases. On these terms, hazard-based regulations are bound to open up new and limitless regulatory and policy vistas, enough to humble the hearts and expectations of rational scientists and citizens. The BfR report concludes ‘the existence of thresholds and non-monotonic dose-response curves are not a hindrance for defining scientific criteria for [hazard] identification.’ Rather than hindrances, dose-response dynamics, thresholds, potencies and exposure levels are concrete realities that sensible regulation ought to be mortified to ignore.

“All this leads to ask why the insane insistence on dimensionless hazards when their real life potency and corollary attributes are measurable in different settings? This insistence claims to be endorsed by all toxicology textbooks, although no such books are cited. By all sensible accounts this insistence is wrong enough to upset Paracelsus in his grave. Operationally, its acceptance would obliterate much of toxicological practice in favor of artless tests for generic adverse effects exclusively open to subjective interpretations. Given the social responsibilities of toxicology and regulation, the use of dimensionless hazards lacks factual and ethical anchors; it can only be seen as laden with the ulterior motives of creative precautionists, interested in regulating whatever comes to mind based on blank flags of hazard. As we know, this would pander to the anxieties of an uninformed public, leading to unjustifiable advocacy and to assuming and costly precautionary policies and regulations, whose public health advantages would not be testable. Should the BfR organize a new and more promising meeting, first addressing basic factual premises?

Read the full editorial: Gio Batta Gori Editorial-Reg Tox Pharmacol-24June2016.

Related Website

The American Chemistry Council provides information about the science, public policy discussion and perspectives on exposures to natural or man-made substances and any potential effects on the endocrine system. It also lists important scientific papers.